| CTRI Number |
CTRI/2021/08/035813 [Registered on: 19/08/2021] Trial Registered Prospectively |
| Last Modified On: |
18/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of Nasya in Vyanga |
|
Scientific Title of Study
|
"Evaluation of Nasya Karma with Varnya Mahakashaya kwath and ksheerpaka in Vyanga" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Parul Sharma |
| Designation |
Assistant.Professor |
| Affiliation |
Rishikul campus Ayurved university Haridwar |
| Address |
Department of Panchkarma Rishikul campus uttarakhand Ayurved University Near Durga Mandir Vikas colony opposite Jamuna Palace Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9808729368 |
| Fax |
|
| Email |
parul.ved@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Parul Sharma |
| Designation |
Assistant.Professor |
| Affiliation |
Rishikul campus Ayurved university Haridwar |
| Address |
Department of Panchkarma Rishikul campus uttarakhand Ayurved University Near Durga Mandir Vikas colony opposite Jamuna Palace Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9808729368 |
| Fax |
|
| Email |
parul.ved@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bharti Mahor |
| Designation |
M.D Scholar |
| Affiliation |
Rishikul campus Ayurved University |
| Address |
Department of Panchkarma Rishikul campus uttarakhand Ayurved University Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
6264670124 |
| Fax |
|
| Email |
drbhartimahor@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rishikul campus,UAU Haridwar |
|
|
Primary Sponsor
|
| Name |
UTTARAKHAND AYURVED UNIVERSITY |
| Address |
UTTARAKHAND AYURVED UNIVERSITY HARRAWALA |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| BHARTI MAHOR |
Rishikul campus,UAU Haridwar |
Department of Panchakarma, OPD no.20 249401 HARIDWAR
Hardwar
UTTARANCHAL |
6264670124
drbhartimahor@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L568||Other specified acute skin changesdue to ultraviolet radiation. Ayurveda Condition: VYANGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Astanghridya su.20/4-6, Procedure details: purvakarma -collection of necessary materials abhyang will be done with tila taila for 15min than sthanik swedana for 5min
pradhan karma- nasya with varnya mahakashaya dravyas kwath (16drops)
paschat karma - sthanik swedana kavalagraha dhumapana
procedure will be done in 3 sittings nasya given for 7 days and there will be 7days of interval in between each sittings )
(1) Medicine Name: Varnya mahakashaya dravya , Reference: charak su. 4/8, Route: Nasal, Dosage Form: Kwatha/Kashaya, Dose: 16(drops), Frequency: od, Duration: 7 Days | | 2 | Intervention Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Astanghridya su. 20/4-6, Procedure details: purvakarma - collection of necessary materials
abhyang will be done with tila tailam for 15 min
sthanik swedana for 5 min
pradhan karma - nasya with varnya mahakashaya dravya ksheerpaka 16drops
paschat karma - sthanik swedana kavalgraha dhumapana
procedure will be done in 3 sittings each sitting will be done for 7days and there will be interval of 7days in between each sitting )
(1) Medicine Name: Varnya mahakshaya , Reference: charaka 4/8, Route: Nasal, Dosage Form: Ksheerpaka, Dose: 16(drops), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient fullfilling the diagnostic criteria of vyanga
2. Patient of age between 22 to 50 years
3. sex both male and female
4. Patient fit for nasya karma |
|
| ExclusionCriteria |
| Details |
1 Skin diseases of face other than melasma (vyanga) ex.acne etc
2 Hyperpigmentation since birth ex.-nevus of ota
3.Subjects with local inflammatory skin disorder such as herpes infection etc.
4.All allergic skin diseases of the face
5. uncontrolled diabetes mellitus and HTN and other previously diagnosed life threatening and complicated systemic disease
6. Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
No improvment-0-24%
Mild improvment- 25-49%
Moderated improvment-51-74%
Marked improvment-75-99%
complete remission- 100% |
15th,29th,42th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| exacerbation in sign and symptoms |
42days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/08/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Melasma is a acquired hyper melanosis which is characterized by development of light to dark brown coloured maculaes that are symmetrically distributed on the sun exposure areas of body . |